JOB SUMMARY
This position is responsible for the data management functions and conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols.
About the Department:
Since its inception as a clinic in 1969 and a division in 1975, we have been dedicated to excellence in patient care, research and education in pediatric hematology and oncology. Our mission is to improve the lives of children with blood disorders and cancer, advance discovery through research, and train the leaders of the future. Pediatric hematology/oncology is a diverse field which includes many areas, including but not limited to:
- Leukemia and lymphoma
- Solid organ cancers
- Brain and spinal tumors
- Bone and soft tissue sarcomas
- Retinoblastoma
- Cancer survivorship
| - Immunodeficiency
- Non-malignant hematology
- Hemostasis and thrombosis
- Sickle cell disease and thalassemia
- Bone marrow failure
- Vascular malformations
|
Across the many diseases within hematology and oncology, we provide state-of-the art clinical care and access to cutting edge therapies and clinical trials. Our faculty include nationally and internationally recognized leaders in the field. We are the only pediatric hematology/oncology program in the state of Tennessee with a unique combination of clinical programs in both hematology and oncology and access to all pediatric subspecialties all within our medical center. Our clinical care is supported by a multi-specialty, multidisciplinary specialty team of physicians, nurses, psychologists, pharmacists, social workers, nutritionists, child life specialists and others who all work together to provide evidence-based family-centered care.
Our team conducts basic science, clinical and population-based research with studies conducted in the United States and abroad. With multi-million dollar funding from the National Institutes of Health, foundations and generous donors, our faculty, staff, trainees and students are committed to new discovery that will lead to prevention, early detection, and treatment for blood disorders and cancer. Our faculty have appointments, including leadership roles in the Vanderbilt-Ingram Cancer Center, the only National Cancer Institute designated comprehensive cancer center in the state of
Tennessee that serves both adults and children.
Education and training are essential to our mission. This includes clinical and research training for medical students, residents, fellows and faculty including those visiting from other institutions in the country and internationally. We have specialized career development grants for fellows and junior faculty.
Position Shift:
- Full Time/Exempt Position
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Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded and your abilities challenged. It is a place where your diversity -- of culture, thinking, learning and leading -- is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.
VUMC Recent Accomplishments
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
* US News & World Report: #1 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.
* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.
* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.
* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.
* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows
* Magnet Recognition Program: Received our third consecutive Magnet designations.
* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement
* Human Rights Campaign Healthcare Equality Index: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
KEY RESPONSIBILITIES:
- Data Management
- Inputs, reviews and submits eligibility documentation into data capture systems for a portfolio of studies. Identifies and resolves any documentation discrepancies.
- Correctly and efficiently abstracts information from the EMR for multiple studies. Able to manage additional assignments as needed for fast accruing studies.
- Identifies AEs from EMR, provides support to correctly and completely record AEs and serves as resource to CTA II staff. Assists with trending reports on AEs for each trial and across teams.
- Submits to sponsor all pertinent data into database accurately and efficiently for Phase I/II/III trials. Acts as preceptor for CTA II staff.
- Reviews and approves responses to sponsor queries from CTA IIs. Supports complex queries and works with sponsors on issues; supports initiatives to reduce queries through identification on ongoing issue
- External Sponsor Monitoring and Visit Management
- Coordinates monitor scheduling for multiple studies, including fast accruing studies with increased monitoring demand and studies with data locks for FDA submissions and/or national meeting presentations.
- Meets with monitors to review data monitoring results, answer questions and resolve queries. Demonstrates effective communication with external monitors. Mentors data team on resolving issues.
- Quality Assurance/Internal Monitoring
- Queries research team to clarify, reconcile and complete data issues. Develops assessment tools to assist clinical staff during patient visits. Mentors and trains CTA II staff to communicate effectively with the research team as needed.
- Identifies and resolves discrepancies with research team. Mentors and assists data team in effective discrepancy resolution as needed.
- Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.
- Trains CTA II staff in good clinical and research practices as it relates to data management as needed. Encourages input as it relates to process improvement.
- Prepares for and participates in clinical trial audits. Mentors and trains CTA II staff to prepare for and participate in internal and external audits as needed.
REQUIREMENTS
- Bachelor's Degree (or equivalent experience) (Required)
- 3 years experience (Required)
